Company: Beckman Coulter, Inc.
Date of Enforcement Report:2/8/2006
Class:lIl
PRODUCT
a) OULTER LH 700 Series Hematology
Analyzer, PN 6605632 and 6605632R,
Recall # Z-0474-06;
b) COULTER GEN.S Series Hematology Analyzer,
PN 6605632, 6605632R; GENS: 6605381,
6605381R, 6605360, 6605360R, 6605470,
6605470R Recall # Z-0475-06
REASON
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
CODE
All software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Beckman Coulter, Inc., Brea, CA, by letter the week of December 19, 2005. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
2,849 units
DISTRIBUTION
Nationwide and Canada
